Status:
UNKNOWN
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
Lead Sponsor:
Nantes University Hospital
Conditions:
Pre-diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diab...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years)
- Subjects with diabetes risk score ≥ 15
- Subjects with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
- Subjects affiliated with an appropriate social security system
Exclusion
- Fasting glycemia ≥ 1.26 g/l
- Fasting glycemia ≤ 1.10 g/l
- Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists.
- Subjects previously treated with insulin, except gestational diabetes
- Severe coagulation disorders
- Thrombocytopenia \< 100 000/mm 3
- Severe psychiatric disorders
- Severe renal insufficiency (creatinine clearance \< 30 ml/min)
- Severe hepatic insufficiency (TP \< 50%)
- Alcohol abuse (\> 30g/j)
- Patient's opposition
- Subject unable to follow the study during the 5 years of follow-up
- Subject exclusion period in a previous study
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT01218061
Start Date
June 1 2010
End Date
June 1 2023
Last Update
June 16 2017
Active Locations (1)
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1
Nantes University Hospital
Nantes, France